2014 ISPE CMO Conference

Schedule-at-a-Glance

Wednesday, 4 June
07:00 - 08:00 Breakfast Session: Breakfast with the Inspectors
  • Moderator: Steven Lynn, Director, Office of Manufacturing and Product Quality, FDA/CDER/OC/OMPQ, USA
  • Ernie Bizjak, Compliance Officer, OHHS/FDA/ORA/OGROP, USA, Invited
  • Rachel Harrington, Supervisory Consumer Safety Officer (GDUFA), FDA/ORA/BLT-DO,
08:30 - 08:40 Drug Shortage: Opening Remarks
  • Leader: Joseph Famulare, VP, Global Compliance and External Collaboration , Pharma Technical Quality, Genentech Inc, USA
  • Leader: Steven Lynn, Director, Office of Manufacturing and Product Quality, FDA/CDER/OC/OMPQ, USA
08:40 - 09:40 Plenary Session with Q&A: Report of the ISPE Drug Shortages Task Force on Emerging Strategies for Preventing and Mitigating Shortages
  • Moderator: Joseph Famulare, VP, Global Compliance and External Collaboration , Pharma Technical Quality, Genentech Inc, USA
  • Moderator: Francois Sallans, Vice President and Chief Quality Officer, Pharmaceutical, Johnson & Johnson, Belgium
  • Gerald Heddell, Dir, Inspection Enforcement and Standards Division, MHRA, United Kingdom
  • Doug Throckmorton, M.D., Deputy Director, Regulatory Programs, FDA/CDER, USA
09:40 - 10:40 ISPE Drug Shortage Updates
10:40 - 11:00 Networking Break
11:00 - 12:00 Industry-Regulatory Roundtable: Implications of the Finding sof the Drug Shortages Task Force
  • Moderator: Joseph Famulare, VP, Global Compliance and External Collaboration , Pharma Technical Quality, Genentech Inc, USA
  • John Berridge, PhD, CChem, FRSC, Pharma Quality & Reg., United Kingdom
  • Sabine Haubenreisser, Ph.D., EMA-FDA Liason, DHHS/FDA/OC/OGROP/OIP, USA
  • Gerald Heddell, Dir, Inspection Enforcement and Standards Division, MHRA, United Kingdom
  • Karen Hirshfield, R.Ph., Senior Compliance Specialist, Genentech-Member of Roche Group, USA
  • Larry Kranking, Executive Director, Commissioning Agents, INC., USA, Invited
  • Steven Lynn, Director, Office of Manufacturing and Product Quality, FDA/CDER/OC/OMPQ, USA
  • Francois Sallans, Vice President and Chief Quality Officer, Pharmaceutical, Johnson & Johnson, Belgium
  • Doug Throckmorton, M.D., Deputy Director, Regulatory Programs, FDA/CDER, USA
  • Sam Venugopal, Director, PricewaterhouseCoopers LLP, USA
  • Frances Zipp, President, Lachman Consultant Services Inc, USA
12:00 - 13:00 Lunch
13:00 - 13:10 Welcome and Introduction - CMO Executive Workshop
13:10 - 13:40 Keynote Presentation
13:40 - 14:10 Keynote Presentation
  • Steve Leonard, Sr VP of Global Operations, Catalent Pharma Solutions, USA
14:10 - 14:40 Keynote Presentation
  • Michael Levy, Senior Counsel, Compliance, FDA/CDER/OC, USA
14:40 - 15:00 Question and Answer Opportunity
15:00 - 15:30 Networking Break
15:30 - 17:30 WORKSHOP 1: The Selection Phase
  • Leader: Courtney Billington, VP, Global Pharmaceutical Supply Chain, Johnson & Johnson, USA
  • Facilitator: James Miller, President, PharmSource Information Services, Inc., USA
Thursday, 5 June
08:00 - 10:00 WORKSHOP 2: The Start-Up Phase
  • Facilitator: James Miller, President, PharmSource Information Services, Inc., USA
10:00 - 10:30 Networking Break
10:30 - 12:30 WORKSHOP 3: The Governance Process
  • Leader: Steve Leonard, Sr VP of Global Operations, Catalent Pharma Solutions, USA
  • Facilitator: James Miller, President, PharmSource Information Services, Inc., USA
12:30 - 13:30 Lunch
13:30 - 15:30 WORKSHOP 4: The Delivery Phase
  • Leader: Wesley Wheeler, CEO, Patheon Inc, USA
  • Facilitator: James Miller, President, PharmSource Information Services, Inc., USA
15:30 - 16:00 Networking Break
16:00 - 17:00 Debrief and Action Items from Workshops and Closing Remarks

Announcements:

MAKE SURE YOUR COMPANY'S VOICE IS HEARD!  

Discussions from the workshops will be collated for the development of a white paper to inform the development of guidance on this topic.

Featured KEYNOTE Speakers

Michael Levy, Senior Counsel, Compliance, FDA/CDER/OC

Courtney Billington, VP, Global Pharmaceutical Supply Chain, Johnson & Johnson

Steve Leonard, Sr. VP, Global Operations, Catalent Pharma Solutions

Thank you to our PROGRAM COMMITTEE!

Tim Tyson, Chairman and CEO, Aptuit, Inc. – Chair

Steve Leonard, Sr. VP, Global Operations, Catalent Pharma Solutions – Co-Chair

Paula Katz, Branch Chief (A), Regulatory Policy & Collaboration, FDA/OMPQ - Co-Chair

Courtney Billington, VP, Global Pharmaceutical Supply Chain, Johnson & Johnson - Co Chair

Joachim Del Boca, Apotheker, Vetter Pharma-Fertigung GmbH & Co KG